69
Participants
Start Date
May 9, 2014
Primary Completion Date
April 28, 2017
Study Completion Date
October 2, 2017
BAY1161909
Given orally, with a starting dose of 0.75 mg twice daily from C1D1 onwards in a 2 days on/5 days off dosing schedule as single agent treatment in Cycle 1 (14 days), and from C2D8 onwards in a 2 days on/5 days off dosing schedule in 28-day cycles. For single-dose PK cohort: a single oral dose on C1D1
Paclitaxel
75 mg/m\^2 (initial dose escalation) or 90 mg/m\^2 (second dose escalation), weekly intravenously (IV) infusion on D1, D8, and D15 of the 28-day cycles from C2D1
Nashville
Detroit
San Antonio
Santa Monica
New Haven
Boston
Lead Sponsor
Bayer
INDUSTRY